Alka-Seltzer Plus Cold Medicine Sparkling Original

Manufacturer
R J General Corporation
Effective date
2018-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:52:39

Label at a glance#

ProductAlka-Seltzer Plus Cold Medicine Sparkling Original
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose nasal and sinus congestion sneezing sore throat temporarily reduces fever

Dosage and administration

adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use

Storage and handling

each tablet contains: sodium 474 mg Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet store at room temperature. Avoid excessive heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purposes
Aspirin 325 mg (NSAID)* Pain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine bitartrate 7.8 mgNasal decongestant

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • headache
    • runny nose
    • nasal and sinus congestion
    • sneezing
    • sore throat
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use to sedate children.

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have
    • asthma
    • diabetes
    • thyroid disease
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
  • nervousness, dizziness, or sleeplessness occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 474 mg
  • Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 60 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-
Seltzer
PLUS®
Aspirin (NSAID) / Pain reliever-
fever reducer • Chlorpheniramine
maleate / Antihistamine • Phenylephrine
bitartrate / Nasal decongestant

COLD
FORMULA

SPARKLING
ORIGINAL

Nasal Congestion • Runny Nose
Headache & Body Ache
Sore Throat • Sinus Pressure

PRINCIPAL DISPLAY PANEL - 60 Tablet Carton
PRINCIPAL DISPLAY PANEL - 60 Tablet Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-1400-36EA - Each0280-1400d9ce5ae8-6625-47f9-ad92-12f7edef8e0512018-12-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70264-01570264-015-01
0280-1400

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Cold Medicine Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.78537dcf-b157-4b67-a8b2-5cb1448151662025-12-04WarningsExact identifier
ndc (product): 0280-1400
f00103df-63f2-2379-e053-2a95a90a716892111477-9137-416e-b1c0-293e5a8551232022-12-17WarningsExact identifier
spl set id: 92111477-9137-416e-b1c0-293e5a855123

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.